***REF IOSS413*** OSSEIOTITE Certain Implant 4 x 13mm*** Sterile using Radiation*** Rx Only***BIOMET 3i Dental Iberica S

FDA device recall Z-2139-2011 · posted 2011-05-04 · Terminated

Recall details

Recalling firm

Biomet 3i, LLC

Reason for recall

Biomet 3i is recalling their product Osseotite Certain Implant Device IOSS413. The internal thread was not manufactured correctly.

Action taken

BIOMET 3i sent an Urgent Medical Device Recall Letter on March 14, 2011, to all affected customers via emial or fax. The letter identified the product, the problem, and the action to be taken by the customer. Customers were told to contact Customer Service at 1-800-342-5454. Customers were instructed to respond with the attached Response Fax or email DomesticComplaints@Biomet.com. If customers still had implant(s) in their inventory, they were to return the implant(s) to BIOMET 3i using the following address: BIOMET 3i Regulatory Compliance Department 4555 Riverside Drive Palm Beach Gardens, Florida 33410 Incident No. CD117886 A replacement implant(s) will be sent to them one the product is returned. For questions regarding this recall call 561-776-6906 (EST 8:00am to 5:00pm).

Root cause

Other

Status

Terminated

Product code

O-FY

Quantity affected

217

Distribution

Worldwide Distribution - USA including AK, FL, GA, NC, NJ, NY, SC and the countries of Canada, Europe, Japan, and South America.

Date initiated

2011-03-10

Date posted

2011-05-04

Date terminated

2012-01-25

Location

Palm Beach Gardens, FL